The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard bowel management
Abdominal massage
Placebo Ultrasound
Sponsored by

About this trial
This is an interventional treatment trial for Constipation focused on measuring massage, abdominal massage, chronic constipation, primary constipation, functional constipation, defecation
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years.
- Diagnosed with chronic constipation according to Rome IV criteria
Exclusion Criteria:
- A recent history of abdominal surgery
- Intestinal obstruction, ileus, colon cancer
- Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
- Umbilical hernia
- Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
- Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event,
- Paraplegia Mental problem to prevent co-operative treatment
- Pregnancy and lactation
Sites / Locations
- Ceren Gursen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Abdominal Massage
Placebo Ultrasound
Arm Description
Outcomes
Primary Outcome Measures
Severity of constipation
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
Secondary Outcome Measures
Patient Assessment of Constipation Quality of life
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. This questionnaire includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
Stool consistency
The stool consistency will be evaluated using the Bristol Stool Scale (BSS), quick and useful indicator of the colonic transit time , a seven-point scale (from 1 to 7), type 1=separate hard lumps, like nuts; 2=sausage shaped but lumpy; 3=like a sausage or snake, but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges; 6=pieces with ragged edges, a mushy stool; 7=water, no solid pieces. While type 1 and 2 indicate hard stool, type 3,4 and 5 show looser (ideal) stool.
Symptoms of constipation
In order to gather information regarding the participants' symptoms of constipation, they will be asked to complete a 7-day bowel diary during the treatment period. This diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, feeling of incomplete evacuation, and changes in food and liquid consumption.
Abdominal pain, abdominal bloating severity and the effect of life
Visual Analogue Scale (VAS): This scale is a 10 cm horizontal line. 0 = no pain / bloating / meaning no effect, 10 = unbearable pain / bloating / experiencing
Physical activity levels
The physical activity levels of the individuals in the last seven days are evaluated under 4 headings (severe activities, moderate activity, walking and sitting). While calculating the total score, the MET-min scores of the patients are obtained by multiplying the duration of activity and frequency of activities (number of days) by the BAT values given to activities (severe activity = 8 MET, moderate activity = 4 MET, walking = 3.3 MET)
Patient global change scale
It is a 7-item scale that evaluates the perception of the change in the effect of constipation and related complaints on the life of the patient compared to the study. The options on this scale are ''much much better'', ''much better'', 'a little better'', ''no change", ''a little worse'', ''much worse'', ''much much worse''
Full Information
NCT ID
NCT03764995
First Posted
December 3, 2018
Last Updated
October 11, 2021
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT03764995
Brief Title
The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
Official Title
The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Since the placebo group is included in the research design, if there is a greater improvement of symptoms of constipation and quality of life in the massage group when compared to the control group, it will be determined that this effect is not related to a placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled design, the therapist effect will be eliminated and further evidence on a well-known massage technique in functional (primary) chronic constipation, a common gastrointestinal problem, will be provided. The results of the present placebo controlled randomized trial will indicate that the need for pharmacological agents and the side effects associated with these agents will be reduced. According to the literature, there are studies that investigate the effects of abdominal massage on symptoms of constipation and quality of life. However, it has generally been used for secondary constipation or two applications have been compared. In addition, there is no randomized placebo-controlled study investigating the effect of abdominal massage on severity of chronic constipation and quality of life.
Detailed Description
Constipation is a subjective symptom that defines as inadequate defecation including several symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. The general prevalence of constipation in adults is 16%. The pre-defined risk factors are women gender, advanced age, non-white ethnicity, low socio-economic level, decreased physical activity underlying diseases, and medications. Chronic constipation affects quality of life and causes problems such as anxiety, depression, somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux, hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.
In the treatment of chronic constipation, conservative approaches (lifestyle change and physiotherapy applications) are used at the first phase. If conservative approaches are not helpful for patients pharmacological and surgical treatment can be performed based on the characteristics of patients, respectively. Pharmacological treatments aim to increase the frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to improve stool consistency. However, side effects such as abdominal bloating, abdominal cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by patients in the following period. Furthermore, medications for constipation management are not cost-effective. Therefore, the level of evidence on conservative approaches with low cost, non-invasive and no-side effects in constipation treatment should be increased.
Physiotherapy approaches to alleviate chronic constipation symptoms include such as defecation training, abdominal massage, connective tissue massage, electrical stimulation, Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application in constipation is used in constipation management since the early 1870s and it is popular in recent years. The benefits of abdominal massage are known as follows: reduction in the abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic movements. The technique of abdominal massage consists of 5 stages as follows: abdominal muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle stroking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
massage, abdominal massage, chronic constipation, primary constipation, functional constipation, defecation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal Massage
Arm Type
Experimental
Arm Title
Placebo Ultrasound
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Standard bowel management
Intervention Description
Lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.
Intervention Type
Other
Intervention Name(s)
Placebo Ultrasound
Intervention Description
Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.
Primary Outcome Measure Information:
Title
Severity of constipation
Description
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
Time Frame
Change in severity of constipation from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Patient Assessment of Constipation Quality of life
Description
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. This questionnaire includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
Time Frame
Change in quality of life from baseline at 4 weeks
Title
Stool consistency
Description
The stool consistency will be evaluated using the Bristol Stool Scale (BSS), quick and useful indicator of the colonic transit time , a seven-point scale (from 1 to 7), type 1=separate hard lumps, like nuts; 2=sausage shaped but lumpy; 3=like a sausage or snake, but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges; 6=pieces with ragged edges, a mushy stool; 7=water, no solid pieces. While type 1 and 2 indicate hard stool, type 3,4 and 5 show looser (ideal) stool.
Time Frame
Change from baseline stool consistency at 4 weeks
Title
Symptoms of constipation
Description
In order to gather information regarding the participants' symptoms of constipation, they will be asked to complete a 7-day bowel diary during the treatment period. This diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, feeling of incomplete evacuation, and changes in food and liquid consumption.
Time Frame
Change from baseline symptoms of constipation at 4 weeks
Title
Abdominal pain, abdominal bloating severity and the effect of life
Description
Visual Analogue Scale (VAS): This scale is a 10 cm horizontal line. 0 = no pain / bloating / meaning no effect, 10 = unbearable pain / bloating / experiencing
Time Frame
Change from baseline symptoms of constipation at 4 weeks
Title
Physical activity levels
Description
The physical activity levels of the individuals in the last seven days are evaluated under 4 headings (severe activities, moderate activity, walking and sitting). While calculating the total score, the MET-min scores of the patients are obtained by multiplying the duration of activity and frequency of activities (number of days) by the BAT values given to activities (severe activity = 8 MET, moderate activity = 4 MET, walking = 3.3 MET)
Time Frame
Change from baseline symptoms of constipation at 4 weeks
Title
Patient global change scale
Description
It is a 7-item scale that evaluates the perception of the change in the effect of constipation and related complaints on the life of the patient compared to the study. The options on this scale are ''much much better'', ''much better'', 'a little better'', ''no change", ''a little worse'', ''much worse'', ''much much worse''
Time Frame
Change from baseline patient global change at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 65 years.
Diagnosed with chronic constipation according to Rome IV criteria
Exclusion Criteria:
A recent history of abdominal surgery
Intestinal obstruction, ileus, colon cancer
Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
Umbilical hernia
Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event,
Paraplegia Mental problem to prevent co-operative treatment
Pregnancy and lactation
Facility Information:
Facility Name
Ceren Gursen
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19217105
Citation
Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.
Results Reference
background
PubMed Identifier
21943617
Citation
Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
Results Reference
background
PubMed Identifier
22098585
Citation
Lamas K, Graneheim UH, Jacobsson C. Experiences of abdominal massage for constipation. J Clin Nurs. 2012 Mar;21(5-6):757-65. doi: 10.1111/j.1365-2702.2011.03946.x. Epub 2011 Nov 21.
Results Reference
background
PubMed Identifier
35554601
Citation
Dogan IG, Gursen C, Akbayrak T, Balaban YH, Vahabov C, Uzelpasaci E, Ozgul S. Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial. Phys Ther. 2022 Jul 4;102(7):pzac058. doi: 10.1093/ptj/pzac058.
Results Reference
derived
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The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
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